Breast cancer metastatic MedDRA version: 9.1 Level: LLT Classification code 10055113 Term: Breast cancer metastatic
Conditions
Interventions
Trade Name: CAELYX
Product Name: Pegylated liposomal doxorubicin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Pegylated liposomal doxorubicin
Concentration unit: mg/
Sponsors
ARCAGY-GINECO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - age > 70 years - HER2-negative breast adenocarcinoma - metastases cytologically or histoogically proven - measurable or assessable disease - life expectancy of at least 3 months Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - metastatic evolution < 6 months - Previous malignancies in last 5 years - patient having received more than 300 mg/m² of Doxorubicin ou more than 300 mg/m² of epirubicin in adjuvant - congestive heart failure or LVEF < 50%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the efficacy of the treatment in term of response rate to a treatment by caelyx administered every 28 days ;Secondary Objective: - Practicability of the treatment - toxicity of chemotherapy - survival analysis - oncologic-geriatric covariables - predictive covariables of hematopoietic reserve and risk of neutropenic fever in old patient ;Primary end point(s): Response rate assessed by imagery according to RECIST criteria and the measurement of CA 15-3, and expressed as percent of patients having a response, a stability or a progression. | — |
Countries
France
Outcome results
None listed